Retinoic Acid Homeostasis in Neuropsychiatric Diseases

• Conditions: Major Depression; Schizophrenia; Alcoholism; Alzheimer's Disease

• Registration Number: NCT02439099
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

It is hypothesized, that local retinoic acid (RA) homeostasis is functionally involved in the pathophysiology of depression. In a cross-sectional (and partly longitudinal) analysis, serum RA status will be assessed in healthy controls and subjects with Major Depression, Alzheimer's disease, alcoholism and in subjects with schizophrenia.

Detailed Description

Retinoids comprise of a group of small-molecule derivatives of Vitamin A with retinoic acid (RA) representing the biologically most active endogenous form. RA has multiple functions central nervous system (CNS). It is hypothesized, that local RA homeostasis is functionally involved in the pathophysiology of numerous neuropsychiatric diseases.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-08
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-09
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• depressive episode in the context of unipolar major depression
• at least 18 points or more on the BDI and HAMD-17

Exclusion Criteria

• additional or comorbid axis-I or axis-II disorder
• current history of any neurological or other serious medical condition
• any psychopharmacological treatment or substance use within the last two weeks or 5 half-lives (whichever is longer) of the respective substance
• any oral or topical application of retinoid-containing preparations within the last 3 months

AD-Group

Inclusion Criteria:

• diagnosed AD

Exclusion Criteria:

• any other neurodegenerative disorder
• any oral or topical application of retinoid-containing preparations within the last 3 months

Schizophrenia-Group

Inclusion Criteria:

• subjects with schizophrenia
• intended therapy with clozapine, olanzapine or aripiprazole
• BMI: 18 - 29,9 kg/m2

Exclusion Criteria:

• presence of diabetes or pathological glucose tolerance
• presence of and chronic inflammatory disease
• any psychopharmacological treatment of clozapine, olanzapine or aripiprazole within the last 3 months
• any oral or topical application of retinoid-containing preparations within the last 3 months

Alcoholism-Group

Inclusion Criteria:

• subjects with alcoholism who either still consume alcohol or are abstinent for at least 4 weeks

Exclusion Criteria:

• any oral or topical application of retinoid-containing preparations within the last 3 months
• current history of any neurological or other serious medical condition despite liver diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum retinoic acid (RA) levels [nM]	Week 0	Serum retinoic acid levels \[nM\] as determined by HPLC according to previously published protocols

Secondary Outcome Measures

Name	Time	Method
For MDD group: MADRS	Week 1, 3, 6	Questionnaire to assess symptom severity in MDD
For MDD group: BDI II	Week 1, 3, 6	Self-rating to assess of symptom severity in MDD
For MDD and schizophrenia Group: Change of serum retinoic acid (RA) levels [nM]	Week 1, 3, 6	Serum retinoic acid levels \[nM\] as determined by HPLC according to previously published protocols
For schizophrenia group: Positive and Negative Syndrome Scale (PANSS) for Schizophrenia	Week 1, 3, 6	Measurement of symptom severity of patients with schizophrenia
For schizophrenia group: Change of metabolic parametres For schizophrenia group:Positive and Negative Syndrome Scale (PANSS)	Week 1, 3, 6	Assessmant of weight, blood pressure, levels of Glucose, HbA1c, cholesterols and dietry

Trial Locations

Locations (1)

Department of Psychiatry, Charité - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany